Immunization of metastatic breast cancer patients with a fully synthetic globo H conjugate: A phase I trial

The carbohydrate antigen globo H commonly found on breast cancer cells is a potential target for vaccine therapy. The objectives of this trial were to determine the toxicity and immunogenicity of three synthetic globo H-keyhole limpet hemocyanin conjugates plus the immunologic adjuvant QS-21. Twenty-seven metastatic breast cancer patients received five vaccinations each. The vaccine was well tolerated, and no definite differences were observed among the three formulations. Serologic analyses demonstrated the generation of IgM antibody titers in most patients, with minimal IgG antibody stimulation. There was significant binding of IgM antibodies to MCF-7 tumor cells in 16 patients, whereas IgG antibody reactivity was observed in a few patients. There was evidence of complement-dependent cytotoxicity in several patients. Affinity column purification supported the specificity of IgM antibodies for globo H. On the basis of these data, globo H will constitute one component of a polyvalent vaccine for evaluation in high-risk breast cancer patients.

L’autorisation inconditionnelle en phase II de l’imperfection du règlement 139/2004 = Unconditional approval in Phase II of the problems of Regulation 139/2004. Research Paper in Law 04/2013

No abstract.

Intraperitoneal bevacizumab for control of malignant ascites due to advanced-stage gastrointestinal cancers: A multicentre double-blind, placebo-controlled phase II study - AIO SUP-0108

PURPOSE: Malignant ascites is debilitating for patients with advanced cancer. As shown previously, tumour cell production of vascular endothelial growth factor might be a major cause of the formation of malignant ascites. Intraperitoneal bevacizumab could therefore be an option for symptom control in refractory ascites. PATIENTS AND METHODS: Patients with advanced gastrointestinal cancer and malignant ascites who had undergone paracentesis at least twice within the past 4 weeks were randomly assigned in a 2:1 ratio to intraperitoneal bevacizumab (400 mg absolute) or placebo after paracentesis. During the 8-week treatment period, a minimum interval of 14 d was kept between the applications of the study drug. Primary end-point was paracentesis-free survival (ParFS). RESULTS: Fifty-three patients (median age 63 years) were randomised. Forty-nine patients received at least one study drug application and qualified for the main analysis. The proportion of patients with at least one common toxicity criteria grade III-V event was similar with 20/33 (61%) on bevacizumab and 11/16 (69%) on placebo. Median ParFS was 14 d (95% confidence interval [CI]: 11-17) in the bevacizumab arm and 10.5 d (95% CI: 7-21) on placebo (hazard ratio 0.74, 95% CI: 0.40-1.37; P = 0.16). The longest paracentesis-free period was 19 d on bevacizumab (range 6-66 d) and 17.5 d in the placebo arm (range 4-42) (P = 0.85). Median overall survival was 64 d (95% CI: 45-103) on bevacizumab compared to 31.5 d (95% CI: 20-117) on placebo (P = 0.31). CONCLUSION: Intraperitoneal bevacizumab was well tolerated. Overall, treatment did not result in a significantly better symptom control of malignant ascites. However, patients defined by specific immune characteristics may benefit.

Application of active and passive suspension techniques to improve high speed ground vehicle performance - phase II. Final report.

Transportation Department, Office of University Research, Washington, D.C.

Test site instrumentation study - phase II. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Pedestrian injury causation parameters. Phase II. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Handling and disposal of sludges from combined sewer overflow treatment : phase II, impact assessment /

Mode of access: Internet.

Field testing, application of combustion modifications to control pollutant emissions from industrial boilers : phase II /

Mode of access: Internet.

Integrated motorist information (IMIS) feasibility and design study. Phase II: generalized methodology for IMIS feasibility studies. Volume 2--validation and application of feasibility study handbook. Final report.

Federal Highway Administration, Office of Research and Development, Washington, D.C.

Experimental evaluation of a portable energy absorbing system for highway service vehicles. Final report for phase II.

Connecticut Department of Transportation, Bureau of Planning and Research, Wethersfield

Eastern lake survey-phase II : national stream survey-phase I : processing laboratory operations report.

Mode of access: Internet.

Methods for aquatic toxicity identification evaluations : phase II toxicity identification procedures /

Mode of access: Internet.

Front passenger aspirator air bag system for small cars. Final technical report. Phase II.

National Highway Traffic Safety Administration, Washington, D.C.

Analysis of typical vehicle repair costs. Phase II. Final report.

National Highway Traffic Safety Administration, Washington, D.C.